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ACTIVE SUBSTANCE / INN

DOLUTEGRAVIR

Brand name(s): DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE, DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE, Tivicay, ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE, DOLUTEGRAVIR, DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE, DOLUTEGRAVIR; RILPIVIRINE, DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
NDA217016
NDA215187
ACTIVE SUBSTANCE
Dolutegravir
REGULATORS
FDA · EMA
SPONSORS / MAH
LAURUS LABS LTD, LUPIN LTD, ViiV Healthcare BV
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATENDA210787LAURUS LABS LTDNone (Tentative Approval)
DOLUTEGRAVIR; RILPIVIRINEANDA213120LUPIN LTDNone (Tentative Approval)
DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINENDA217016STRIDES PHARMANone (Tentative Approval)
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINEANDA216223LAURUS LABS LTDNone (Tentative Approval)
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDENDA214544LUPIN LTDNone (Tentative Approval)
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATENDA209670MYLAN PHARMS INCNone (Tentative Approval)
DOLUTEGRAVIRNDA215319LAURUS GENERICS INCPrescription
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATENDA212303LUPIN PHARMSNone (Tentative Approval)
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDENDA215187LUPIN PHARMSNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TivicayViiV Healthcare BVAuthorised16/01/2014HIV Infections

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